ProVectra 3D Prime with VistaSoft

K181432 · Durr Dental SE · OAS · Aug 2, 2018 · Radiology

Device Facts

• Record ID: K181432
• Device Name: ProVectra 3D Prime with VistaSoft
• Applicant: Durr Dental SE
• Product Code: OAS · Radiology
• Decision Date: Aug 2, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

ProVecta 3D Prime is computed tomography x-ray unit intended to generate 3D and panoramic X-ray images in dental radiography for adult and pediatric patients. It provides diagnostic details of the maxillofacial areas for a dental treatment. The device is operated and used by physicians, dentists, and x-ray technicians. Not intended for mammography use. VistaSoft: The VistaSoft software functions for recording, displaying, analyzing, diagnosing, managing and sending digital or digitized video and X-ray images in dental practices and specialist dental clinics. Not intended for mammography use.

Device Story

ProVecta 3D Prime is a cone beam CT (CBCT) dental imaging system. Input: X-ray tube and sensor rotate 180°-540° around a patient, emitting a conical beam to acquire 2D projection images. Transformation: Reconstruction computer processes 2D projections into a 3D volume graphic of voxels; VistaSoft software manages, displays, and analyzes these images. Output: 3D volumes and 2D tomographic sectional images. Used in dental clinics by dentists, physicians, and technicians. Healthcare providers use the output for diagnostic visualization of teeth, osseous structures, and sinuses to plan dental treatments. Benefits include precise anatomical assessment for maxillofacial procedures.

Clinical Evidence

No clinical trials required for substantial equivalence. Bench testing performed to ensure diagnostic quality, confirming good contrast and resolution for teeth, osseous structures, and sinus maxillaries. Biocompatibility testing (cytotoxicity, chemical, biological) performed on patient-contact components (bite block, forehead support).

Technological Characteristics

CBCT system; 50-99 kV tube voltage; 4-16 mA tube current; 0.5 mm focal spot; 2.8 mm Al filtration. Uses Xmaru1404CF detector. Connectivity: DICOM 3.0 compatible. Software: VistaSoft (derived from K161444). Mechanical: Compact design with bite block, chin rest, and headrest. Sterilization: Bite block supports steam sterilization.

Indications for Use

Indicated for adult and pediatric patients requiring 3D and panoramic X-ray imaging of maxillofacial areas for dental treatment. Not indicated for mammography.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• PaX-i3D Smart (PHT-30LFO) (K152106)

Reference Devices

• DBSWIN and VistaEasy Imaging Software (K161444)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the words "U.S. FOOD & DRUG ADMINISTRATION" on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the text.

August 2nd, 2018

Durr Dental SE % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114

Re: K181432

Trade/Device Name: ProVectra 3D Prime with VistaSoft Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: May 29, 2018 Received: June 1, 2018

Dear Mr. Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jeff Rogers

for Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K181432

Device Name ProVectra 3D Prime with VistaSoft

# Indications for Use (Describe)

ProVecta 3D Prime:

ProVecta 3D Prime is computed tomography x-ray unit intended to generate 3D and panoramic X-ray images in dental radiography for adult and pediatric patients. It provides diagnostic details of the maxillofacial areas for a dental treatment. The device is operated and used by physicians, dentists, and x-ray technicians. Not intended for mammography use.

VistaSoft:

The VistaSoft software functions for recording, displaying, analyzing, diagnosing, managing and sending digital or digitized video and X-ray images in dental practices and specialist dental clinics. Not intended for mammography use.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary, DÜRR DENTAL SE, ProVecta 3D Prime with VistaSoft

### K181432

This 510(k) is being submitted in accordance with the requirements of 21 CFR §807.92.

#### 1. Date Summary Prepared:

July 26, 2018

#### 2. Submitter's Identification:

DÜRR DENTAL SE Höpfigheimer Str. 17 74321 Bietigheim-Bissingen Deutschland/Germany Phone: + 49 (0) 7142 70 5-0 Fax: + 49 (0) 7142 705-500 E-Mail [e-mail] Internet: www.duerrdental.com

### Contact:

Oliver Lange Head of Quality Management Email: lange.o@@duerr.de

### U.S. Contact:

Suzanne Lucas Air Techniques, Inc. 1295 Walt Whitman Road Melville, NY 11747 Tel: [phone] Email: [e-mail]

#### 3. Device:

Trade /Proprietary Name: Device: Regulation Description: Regulation Medical Specialty: Review Panel Product Code Regulation Number Device Class

ProVecta 3D Prime with VistaSoft X-Ray, Tomography, Computed, Dental Computed tomography x-ray system. Radiology Radiology OAS 892.1750 2

#### 4. Predicate Device:

Legally Marketed Predicate Device Information: 510(k) Number: K152106 Manufacturer: Vatech Co. Ltd. Trade /Proprietary Name PaX-i3D Smart (PHT-30LFO) Device: X-Ray, Tomography, Computed, Dental

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| Regulation Description: | Computed tomography x-ray system. |
|-------------------------------|-----------------------------------|
| Regulation Medical Specialty: | Radiology |
| Review Panel | Radiology |
| Product Code | OAS |
| Regulation Number | 892.1750 |
| Device Class | 2 |

The Dental tomography x-ray system requires our VistaSoft Software, modified from what was cleared in: K161444 Trade/Device Name: DBSWIN and VistaEasy Imaging Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ

#### 5. Device Description:

This device is a cone beam CT x-ray device for the acquisition of dental images. Similar to computer tomography or magnetic resonance tomography, sectional images can be generated with CBCT. With CBCT, an X-ray tube and an imaging sensor opposite it rotate around a seated or standing patient. The X-ray tube rotates through 180°-540° and emits a conical X-ray beam. The X-rays pass through the region under investigation and are measured for image generation by a detector as an attenuated grey scale X-ray image. Here, a large series of two-dimensional individual images is acquired during the revolution of the X-ray tube. Using a mathematical calculation on the rotating image series via a reconstruction computer, a grey value coordinate image is generated in the three spatial dimensions. This three-dimensional coordinate model corresponds to a volume graphic that is made up of individual voxels. This volume can be used to generate sectional images (tomograms) in all spatial dimensions as well as 3D views. The system complies with US Radiation Safety Performance Standard.

Image /page/4/Figure/4 description: The image shows a piece of equipment with several parts labeled with numbers. Number 1 is pointing to a circular object, while number 2 is pointing to a square object. Numbers 3, 4, and 5 are pointing to different parts of the equipment's structure, and numbers 6 and 7 are pointing to a screen-like component.

- 1 Emergency stop switch
- 2 On/off switch
- 3 X-ray tube
- 4 C-shaped elbow
- 5 Status LED
- 6 Operating elements
- 7 Memory card slot

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#### 6. Indications for use:

ProVecta 3D Prime is computed tomography x-ray unit intended to generate 3D and panoramic X-ray images in dental radiography for adult and pediatric patients. It provides diagnostic details of the maxillofacial areas for a dental treatment. The device is operated and used by physicians, dentists, and x-ray technicians. Not intended for mammography use.

The VistaSoft software features functions for recording, displaying, analyzing, diagnosing, managing and sending digitized video and X-ray images in dental practices and specialist dental clinics. Not intended for mammography use.

### 7. Summary of the technological characteristics of the device compared to the predicate devices:

| Descriptive Information | K152106, PaX-i3D Smart<br>(PHT-30LFO) Vatech Co., Ltd. | ProVecta 3D Prime with<br>VistaSoft DÜRR DENTAL SE | |
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Indications for Use | PHT-30LFO is a computed<br>tomography x-ray system<br>intended to produce<br>panoramic, cephalometric or<br>cross-sectional images of the<br>oral anatomy on a real time<br>basis by computer<br>reconstruction of x-ray image<br>data from the same axial<br>plane taken at different<br>angles. It provides diagnostic<br>details of the anatomic<br>structures by acquiring 360°<br>rotational image sequences<br>of oral and maxillofacial area<br>for a precise treatment<br>planning in adult and<br>pediatric dentistry. The<br>device is operated and used<br>by physicians, dentists, and<br>x-ray technicians. | ProVecta 3D Prime is computed<br>tomography x-ray unit intended to<br>generate 3D and panoramic X-<br>ray images in dental radiography<br>for adult and pediatric patients. It<br>provides diagnostic details of the<br>maxillofacial areas for a dental<br>treatment. The device is<br>operated and used by physicians,<br>dentists, and x-ray technicians.<br>Not intended for mammography<br>use. The VistaSoft software<br>features functions for recording,<br>displaying, analyzing, diagnosing,<br>managing and sending digital or<br>digitized video and X-ray images<br>in dental practices and specialist<br>dental clinics. Not intended for<br>mammography use.<br>Main difference: This unit does<br>not support the cephalometric<br>mode. | |
| Image Acquisition Modes | Panoramic, cephalometric<br>and computed tomography | Panoramic and computed<br>tomography | |
| Imaging Software | EasyDent: 2D viewer and<br>patient management<br>software<br>Ez3D Plus : 3D viewer and<br>image analysis software | VistaSoft, includes 2D and 3D | |
| Input Voltage | AC 100-240 V | AC 200-240V | |
| Tube Voltage | 50-99 kV | 50-99 kV | |
| Tube Current | 4~16 mA | 4~16mA | |
| Descriptive Information | | K152106, PaX-i3D Smart<br>(PHT-30LFO) Vatech Co., Ltd. | ProVecta 3D Prime with<br>VistaSoft DÜRR DENTAL SE |
| Focal Spot Size | | 0.5 mm | 0,5 mm |
| Exposure Time | | Max. 18 s | Max. 16.4s |
| Slice Width | | 0.1 mm min. | 0.1 mm min. |
| Total Filtration | | 2.8 mm Al | 2.8 mm Al |
| Chin Rest | | Equipped Headrest | Bite block, chin rest and<br>headrest |
| Mechanical | | Compact design | Compact design |
| Electrical | | LDCP logic circuit (Low Dark<br>Current Processing) | LDCP logic circuit (Low<br>Dark Current Processing) |
| Software | | DICOM 3.0 Format<br>compatible | VistaSoft, DICOM 3.0<br>compatible |
| 2D Image Viewing Program | | EasyDent | VistaSoft |
| 3D Image Viewing Program | | Ez3D Plus | VistaSoft |
| Anatomical Sites | | Maxillofacial | Maxillofacial |
| Image<br>Receptor | Computed<br>Tomography | Xmaru1404CF | Xmaru1404CF |
| Note: CT<br>and | Panoramic | Xmaru1404CF | Xmaru1404CF |
| panoramic<br>image<br>performance<br>is identical<br>because the | MTF @ 2.5<br>lp/mm | >8% | >8% |
| | Noise, RMS of<br>Dark current | ADU<3 | ADU<3 |
| sensors are | Cephalometric | Xmaru2301CF<br>1210SGA<br>910SGA<br>Xmaru2301CF-O | N/A functionality not<br>available |
| identical. | | | |
| | | | |
| | | | |
| Size of Imaging Volume<br>(cm) | | Xmaru1404CF : Max. 10x8.5 | Xmaru1404CF : Max.<br>10x8.5 |
| Pixel<br>Resolution | Computed<br>Tomography | Xmaru1404CF :<br>- 5.0 lp/mm - 2x2 binning<br>- 2.5 lp/mm - 4x4 binning | Does not support 5.0<br>lp/mm - 2x2 binning<br>2.5 lp/mm - 4x4 binning |
| | Panoramic | Xmaru1404CF :<br>- 5.0 lp/mm - 2x2 binning<br>- 2.5 lp/mm - 4x4 binning | Does not support 5.0<br>lp/mm - 2x2 binning<br>2.5 lp/mm - 4x4 binning |
| | Cephalometric | Xmaru2301CF : 5 lp/mm<br>1210SGA : 3.9 lp/mm<br>910SGA : 3.9 lp/mm<br>Xmaru2301CF-O : 5 lp/mm | N/A functionality not<br>available |
| Descriptive Information | | K152106, PaX-i3D Smart<br>(PHT-30LFO) Vatech Co., Ltd. | ProVecta 3D Prime with<br>VistaSoft DÜRR DENTAL SE |
| Pixel Size | Computed<br>Tomography | Xmaru1404CF :<br>- 99 $\mu$ m- 2x2 binning<br>- 198 $\mu$ m- 4x4 binning | Xmaru1404CF :<br>99 $\mu$ m - 2x2 binning<br>198 $\mu$ m- 4x4 binning |
| | Panoramic | Xmaru1404CF :<br>- 99 $\mu$ m- 2x2 binning<br>- 198 $\mu$ m- 4x4 binning | Xmaru1404CF :<br>99 $\mu$ m - 2x2 binning<br>198 $\mu$ m- 4x4 binning |
| | Cephalometric | Xmaru2301CF : 100 x 100 $\mu$ m | N/A functionality not<br>available |
| | | 1210SGA : 127 x 127 $\mu$ m | |
| | | 910SGA : 127 x 127 $\mu$ m | |
| | | Xmaru2301CF-O : 100 x 100 $\mu$ m | |
| Photograph | | | |

### Summary of the Technological Characteristics

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#### 8. Discussion of Similarities and Differences:

The two systems share certain common components including the main digital imaging panel and the X-ray tube, Monobloc, MCU, and Power boards. However the mechanical parts as well as the exterior of the device are Dürr Dental developments. The software, while functionally similar, is different, having been derived from our own software cleared in K161444, Trade/Device Name: DBSWIN and VistaEasy Imaging Software. That software required only minor changes in order to recognize the added hardware compatibility of the scanning detector. The key performance difference is that we do not support cephalometric testing.

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#### 9. Non-Clinical Data and Performance Testing

Testing to the following IEC and DIN Standards was successfully performed: IEC 60601-1 Medical Electrical Equipment, Part I: General requirements for basic safety and essential performance

IEC 60601-1-2 Medical Electrical Equipment, Part l-2: General requirements for basic safety and essential performance. Collateral Standard : Electromagnetic Compatibility IEC 60601-1-3 General Requirements for Radiation Protection in Diagnostic X-Ray Equipment

IEC 60601-1-6 General requirements for basic safety and essential performance -Collateral standard: Usability

IEC 60601-2-63 Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment

IEC 60825-1 Safety of laser products - Part 1: Equipment classification and requirements IEC 62304 Medical Device Software Life-cycle processes

IEC 62366 Medical devices - Application of usability engineering to medical devices DIN 6868-151 Image quality assurance in diagnostic X-ray departments - Part 151: Acceptance testing of dental radiographic equipment accordance to ROEV - Rules for the inspection of image quality after installation, maintenance and modification

DIN 6868-161 Image Quality Assurance In Diagnostic X-Ray Departments - Part 161: ROEV Acceptance Testing Of Dental Radiographic Equipment For Digital Cone-Beam Computed Tomography

Software and firmware was evaluated in accordance with the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Risk management activities were documented.

Biocompatibility Assessment:

The Bite Block received the following evaluations:

Cytotoxicity Testing

Chemical Analysis Testing

Biological Safety Testing

The forehead support with cushion received the following evaluation: Cytotoxicity testing.

Other patient contact components had already received their own FDA clearances. Cleaning, Disinfection and Sterilization Testing:

Bite block manual cleaning and Disinfection Testing was performed.

Bite block mechanical cleaning and Disinfection Test was performed.

Bite Block Steam sterilization Test was performed.

Pediatric considerations: Labeling included the recommendations of the FDA Guidance: "Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff Document issued on November 28, 2017." Cybersecurity considerations: Labeling also included cybersecurity strategy information based on FDA's cybersecurity guidance, "Postmarket Management of Cybersecurity in Medical Devices" dated December 28, 2016."

- 10. Clinical Data: Not required for a finding of substantial equivalence (because the same detector as the predicate is used) but performed to assure diagnostic quality of the dental images. The overall impression is sufficient for dental diagnostics. Good contrast and good resolution. Teeth, osseous structures, sinus maxillaries are clearly shown.

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### 11. Conclusion:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the similarity to the predicate device in terms of technology, performance and indications for use, DÜRR DENTAL SE concludes that the ProVecta 3D Prime with VistaSoft is substantially equivalent to the predicate device as described herein.

The differences between the new device and the predicate device shown in the comparison table above do not raise any new questions about safety and effectiveness and so we consider it substantially equivalent to the predicate device.